drugset / Trial / NCT02011763

Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) in Toddlers, Children and Adolescents

NCT02011763

Phase 4 Completed 355 enrolled Sanofi Pasteur, a Sanofi Company
NaSingle-groupOpen-labelPrevention

Summary

The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to confirm the good safety profile of the vaccine. Primary objective: * To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered 6 months apart, in subjects aged 12 months to 15 years.

Timeline

Start
2013-12
Primary completion
2014-09
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Havrix Vaccine 0.5 ml Intramuscular